Search Results

The Red Light is intended to treat full face wrinkles.
The Blue Light is intended to treat mild to moderate inflammatory acne.
The Yellow Light is intended to treat wrinkles.

The GLAM LED light therapy mask is a home use wearable light emitting diode phototherapy device whose purpose is to produce an even, cool, narrow band of light for the treatment of full face wrinkles and mild to moderate acne of the face. The outer shell of the mask is manufactured from Polyethylene terephthalate (PET). The inner shell is a clear Polycarbonate (PC). The Light emitting diodes are mounted behind the clear Polycarbonate. The LEDs generate the light. The ear hooks are made of Acrylonitrile butadiene styrene (ABS) and the silicone goggle protect the eyes from LED lights. Unfold the ear hooks and place the mask on your face, the mask will automatically activate the light therapy mode. The LEDs produce blue, red and yellow light in the visible spectrum (Blue:415nm +/- 10nm, Yellow: 590nm +/-10nm, Red: 625nm +/-10nm.). The device works by emitting the specified wavelengths to treat full face of wrinkles or to treat mild to moderate inflammatory acne. Press the touch switch on the right ear hook twice to select the light therapy mode you want to use. Each mode operates in a 15-minute cycle. After 15 minutes, the device automatically deactivates the light mode and enters the standby mode.

This FDA 510(k) clearance letter for the GLAM LED Facial Mask (TB-2386F) does not include any information regarding clinical testing, acceptance criteria for device performance related to efficacy (e.g., wrinkle reduction or acne treatment), or studies comparing the device's performance against such criteria.

The letter focuses on the substantial equivalence based on:

• Technological Comparison: Comparing light wavelengths, power density, and treatment time to predicates.
• Safety Standards Compliance: Verification through non-clinical tests (electrical safety, EMC, biocompatibility, photobiological safety, software verification).

Therefore, I cannot provide details on the specific acceptance criteria for efficacy or a study proving the device meets those criteria from the provided document. The 510(k) summary explicitly states: "No animal or clinical study is included in this submission."

However, if we were to hypothesize what acceptance criteria and a study might look like for a device with these indications, and then illustrate what would be missing from this document:

Hypothetical Acceptance Criteria and Performance Study (Not Found in Provided Document):

Since the provided document explicitly states no clinical study was included, the following tables and sections represent what would typically be expected for a device claiming therapeutic efficacy, but none of this information is present in the provided 510(k) clearance letter.

Hypothetical Acceptance Criteria and Reported Device Performance (If Clinical Data Existed)

Ask a specific question about this device

The IPL Hair Removal Device (Model: TB-1755) is an Over the Counter device intended for the removal of unwanted body hair.

IPL Hair Removal Device Model: TB-1755, a small over-the-counter device for the permanent reduction of hair growth based on Intense Pulsed Light (IPL). It works below the skin's surface and does not involve any cutting or pulling, reducing hair growth with minimal pain. A personal Light-Based Hair Removal System. Emission activation is by finger switch. Device includes a treatment window head, an adaptor and goggles. The size of the device is about 185 x 72.4 x 69.2mm (H x W x D). The device incorporates Intense Pulse Light (IPL) technology. The purpose of the light is to heat the root where the hair grows. The device contains a Xenon Lamp and a skin proximity sensor to detect appropriate skin contact. If the IPL Hair Removal Device is not properly applied to the treatment area (in full contact with the skin), the device cannot be triggered a pulse emitting.

The provided text is a 510(k) Summary for an IPL Hair Removal Device (Model: TB-1755). This document focuses on demonstrating substantial equivalence to existing predicate devices, rather than presenting a detailed study with specific acceptance criteria and performance data for the subject device in the way one might expect for a diagnostic or AI-driven device.

Therefore, the requested information, specifically regarding acceptance criteria, reported performance from a study, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details, is largely not present in this type of regulatory submission.

Here's an explanation based on the provided text, highlighting what is available and what is not:

Request for Acceptance Criteria and Device Performance Study

The provided document, a 510(k) Summary, describes a process for market clearance based on "substantial equivalence" to legally marketed predicate devices, not on proving absolute efficacy against predetermined acceptance criteria for a novel device through a clinical study. As such, the specific information requested in your prompt detailing acceptance criteria and performance statistics of a study is not explicitly available in this document.

The "study" mentioned mainly refers to bench testing against recognized safety and performance standards for medical electrical equipment and biological evaluation (e.g., IEC and ISO standards), and a comparison of the subject device's specifications and indications for use against predicate devices.

Here's what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance

• Acceptance Criteria (Implicit): The implicit acceptance criteria are that the device adheres to the relevant IEC and ISO standards listed for safety (electrical, EMC, biological evaluation) and that its performance specifications (e.g., wavelength, fluence, pulse duration) are similar to or within the ranges of the predicate devices, and do not raise new questions of safety or effectiveness.
• Reported Device Performance: No explicit performance data (e.g., hair reduction percentage, adverse event rates in a clinical trial) from a specific study on the subject device is reported in this summary. The summary focuses on showing that the device meets standards and is comparable to already cleared devices.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not provided. This document does not describe a clinical test set or participant sample size for evaluating hair removal efficacy. The "tests" mentioned are primarily laboratory bench tests for compliance with electrical, electromagnetic, and biocompatibility standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable/Not provided. This type of information is pertinent to studies involving expert review for diagnostic accuracy or clinical outcomes, which is not the focus of this 510(k) summary.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable/Not provided. The testing mentioned is for technical compliance and safety, not for clinical adjudication of outcomes.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not applicable/Not provided. This device is an IPL hair removal device, not a diagnostic imaging device involving human readers or AI assistance in interpretation.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable/Not provided. This is not an AI-driven device or an algorithm for standalone performance evaluation.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Implicit Ground Truth for Bench Tests: The "ground truth" for the bench tests is adherence to the specifications defined by the referenced IEC and ISO standards and the performance characteristics observed in the laboratory environment. For the substantial equivalence argument, the "ground truth" is that the predicate devices are legally marketed and considered safe and effective for their intended use.
• No clinical outcomes data as ground truth is described for the subject device.

8. The sample size for the training set

• Not applicable/Not provided. This applies to machine learning models, which is not relevant to this device.

9. How the ground truth for the training set was established

• Not applicable/Not provided. As above, this is not a machine learning device.

Summary of available information related to "testing" and "performance":

The "Test Summary" section (Section 7) on page 5 details that the IPL Hair Removal Device's safety and performance were evaluated by lab bench testing according to several standards:

• Safety Standards (Electrical, EMC, Home Healthcare, Specific to non-laser sources):
  • IEC 60601-1 (General Safety)
  • IEC 60601-1-2 (Electromagnetic Compatibility - EMC)
  • IEC 60601-1-11 (Home Healthcare Environment)
  • IEC 60601-2-57 (Non-laser source equipment for therapeutic/cosmetic use)
• Biological Evaluation Standards:
  • ISO 10993-5 (In Vitro Cytotoxicity)
  • ISO 10993-10 (Irritation and Skin Sensitization)
• Software Guidance:
  • Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (Indicates software control is present, as seen in the comparison table)

The "Comparison to Predicate Device" section (Section 8) on pages 5-6 indicates that the subject device's design principles, intended use, indications for use, functions, material, and applicable standards are "very similar" to the predicate devices. Differences in specifications like wavelength range, spot size, max fluence, pulse duration, and output energy are noted but deemed not to affect safety and effectiveness because they are "similar to the predict devices', or under their ranges" and the "safety and effectiveness of the subject device is verified via tests" (referring to the bench tests mentioned above).

Conclusion: The document confirms that the device underwent specific technical and biological safety tests to demonstrate compliance with recognized standards. However, it does not include data from a clinical effectiveness study with human participants, specific acceptance criteria for hair removal efficacy, or the other detailed study parameters requested in your prompt. The clearance is based on substantial equivalence, relying on the established safety and effectiveness of the predicate devices and the subject device's compliance with safety standards.

Ask a specific question about this device